Vocational training center for

undergraduate university students

and teachers in Jordan (VTC)
(Project no.: 561708-EPP-1-2015-1-DE-EPPKA2-CBHE-JP)

1
 ISO 9001:2015
Quality Management Systems

Paulo & Beatriz – Consultores Associados, Lda

Paulo Baptista / Beatriz Marques
Portugal, 17th and 18th April 2017

2
Learning Objectives
• The history and
development of ISO 9001
• What is a Quality
Management System
(QMS)
• The benefits of a QMS
Have the skills to develop
documentation :
• process mapping
• documented information such as
procedure and supporting
document

KNOWLEDGE SKILLS

• The terms and definitions

used
• Key concepts, principles
and structure
• The main requirements of
ISO 9001:2015 and how
to implement
……QMS shall establishing the
documented information for the
effectiveness (Clause 7.5
9001:2015)

3
Solution & Result...
training journey

1 2 3 4

Overview Knowledge Identification Documentation

The Need for Understanding the Develop your Discover how you
Quality requirements of the expertise to can develop the
Management standard is your identify the documentation
System essential starting document and system
point to working with other to comply
a management the requirement
system.

4
 Module 4
Interpretation &
Documentation of Context
Module 2 Organisation
Overview Module 3
ISO 9001 - General • Interested Party
• Principle of QMS • Scope
Module 1 • Terminology • Process Mapping (Workshop 2)
(Workshop 1) • Historical of ISO 9001
• Concept of Quality • ISO 9000, ISO 9001 & ISO
9004

Module 5
Interpretation &
Module 9 Module 8
Documentation of
Interpretation & Interpretation &
Leadership
Documentation of Documentation of
Performance Evaluation Operation
• Commitment
• Quality Policy
• Customer Satisfaction • Planning and provision of services ((Workshop 5) • Role & Responsibility
• Internal Audit • Control of external providers
• Management Review • Release & Control of Non Conforming

Module 10 Module 7 Module 6

Interpretation & Interpretation & Interpretation &
Documentation of Documentation of Documentation of Planning
Improvement Resources

• Improvement • People • Risk Management

• Nonconformity & Corrective action • Infrastructure (Workshop 3)
• Continual Improvement) • Process Environment • Quality Objective
• Monitoring & Measurement • Management of Change
• Knowledge Management)
Closing • Competence
• Awareness
• Documented Information(Workshop 4
5
 1

Concept of Quality

6
 Quality ?

Quality
Quality Assurance
Control
Quality Management

7
 (ISO 9001:2015)
ZERO DEFECT CONTINUOSLY &
Q Performance
INTERESTED PARTIES SATISFACTION SUSTANAIBILITY

(ISO 9001:2008)
CUSTOMERS SATISFCATION CONSISTENTLY
QUALITY
MANAGEMENT
ZERO DEFECT CONTINUOSLY &
CUSTOMERS SATISFCATION
Quality
Assurance PERFORMANCE
ZERO DEFECT CONTINUOSLY
Quality Control

ZERO DEFECT
COMPLIANCE
Quality Inspection

Non Quality Culture

Time

8
comprehensive portfolios ensure your corporate reputation remains secure

9
 Key terms and definitions
Management ?
“Coordinated activities to direct and
control an organization”

Quality Management ?
“Management with regard to quality”

Quality Management System ?

“Management system with regard to
quality”

10
11
 2

Management Principle

12
Key concepts : 7 Management
Principles

Evidence-
Customer Engagement Process Improvemen based Relationship
Leadership
Focus of People Approach t Decision Management
Making

13
 Key concepts : Process Approach
• A Coherent System:

(Interactions)
• Activities
understood
and managed as
• Understanding (Outputs)
interrelated
requirements (Inputs)
processes
Process
Intended
results

Consistent,
predictable results
• Processes adding value
Processes providing effective performance Meeting requirements
Improvements (through evaluation) of data/information Customer satisfaction
PDCA (process) methodology

14
 3

ISO 9000 Family

15
ISO 9001 – History
ISO 9003 – 1987
EN 29003 - 1987

ISO 9002 – 1987

EN 29002 - 1987
ISO 9001 – 1987 Quality systems
EN 29001 - 1987
Part 1. Specification for final inspection
and test
Quality systems

Part 1. Specification for production

Quality systems and installation

Part 1. Specification for design/development,

production, installation and servicing

16
Evolution of ISO 9000

ISO 9001

1st edition : 2nd edition : 3rd edition : 4th edition : 5th edition :
ISO 9001:1987 ISO 9001:1994 ISO 9001:2000 ISO 9001:2008 ISO 9001:2015
ISO 9002:1987 ISO 9002:1994
ISO 9003:1987 ISO 9003:1994

ISO 9001 ISO 9000 ISO 9004

British Standards British Standards

Standards Publication

Quality Management Quality management Managing for the

systems – Requirements systems – Fundamentals sustained success of an
and vocabulary organization — A quality
management approach

17
 Accredited Certification

International Accreditation Forum Establishes Multilateral Recognition Arrangements

Certified once, accepted everywhere Mandatory Documents

Personnel eg IRCA
Accreditation Body local national body
Certification Body

Accredits Certificates Accredits

Certification body
Training Course,
Certification Body Auditor Tutor,
User Trains Training Body

Organization Audits

18
 CERTIFICATION PROCESS – ISO 9001
Renewal Certification Process

Receive Min. 3 weeks before audit

6-monthly
Manual &
Stage 2 Surveillance
Procedure
Pre- Audit Audit
Audit

Stage 1
Y
Audit major 3 year
Corrective major N
Action
Y
Y
OPTIONAL
Corrective
Corrective Actions
Actions Max. Max.
major
3 3
months months
Corrective
Actions Follow-up
Follow-up audit
audit

19
Clause of ISO 9001:2015
11 Scope 6
6 Planning

22 Normative references 7
7 Support

33 Terms and definitions 8

8 Operation

44 Context of the organization 9

9 Performance evaluation

55 Leadership
10
10 Improvement

20
 this particular Management System Standard (MSS) is
addressed, and this includes the ‘intended result(s)’ of the
application of this Standard. These have already in the main
been addressed through the promotion of the process
approach, namely:
• Consistent provision of products and services that meet
customer and applicable statutory and regulatory
1) Scope requirements (legal requirements)
• ‘Intended outcome’ is that which is ‘intended’ as a result of
the application of the standard, or process etc.
• ‘Expected outcome’ is that which is ‘expected’ by interested
parties

2) Normative cites ISO 9000:2015 Quality Management

references Systems – Fundamentals and vocabulary
as indispensable for its application

3) Terms and
definitions

21
22
 4

Context of Organisation
Clause 4 - ISO 9001:2015

23
4. Context of the organization
4.1. Understanding the organization and its context
The organization shall determine external and
internal issues that are relevant to its purpose
and its strategic direction and that affect its ability to
achieve the intended result(s) of its quality
management system.
The organization shall monitor and review information
about these external and internal issues.

24
 Understand the ‘Context of your
Organization’
Determine:
Intended
Purpose result(s) of
QMS External
and
and internal
strategic
issues
direction

Organization
Applicability

Boundaries
and Interested
Products and
applicability parties
services
(Scope) relevant to
Requiremen the QMS
ts of these
interested
parties

25
4.2. Understanding the needs and expectations of
interested parties
Due to their effect or potential effect on the organization’s
ability to consistently provide products and services that
meet customer and applicable statutory and regulatory
requirements, the organization shall determine:
a) the interested parties that are relevant to the quality
management system;
b) the requirements of these interested parties that are
relevant to the quality management system.
The organization shall monitor and review information
about these interested parties and their relevant
requirements.

26
Clause 4: Context of the Organization
(2)
4.2. Understanding the needs and expectations of interested
parties Citizens The Organization Competitors
Customers Management Media
Distributors • Top Management Commentators
• Those accountable for
Shareholders Trade groups
Quality policy and
Investors implementation Neighbors
Owners Those who implement Pressure groups
and maintain the QMS
Insurers Emergency services
• Those who maintain
Government QMS and risk Other response agencies
Regulators procedures Transport services
Recovery service Other Staff Staff dependents
suppliers Contractors

27
4.3. Determining the scope of the quality management
system
The organization shall determine the boundaries and
applicability of the quality management system to
establish its scope.
When determining this scope, the organization shall
consider:
a) the external and internal issues referred to in 4.1;
b) the requirements of relevant interested parties
referred to in 4.2;
c) the products and services of the organization.

28
The organization shall apply all the requirements of
this International Standard if they are applicable
within the determined scope of its quality
management system.
The scope of the organization’s quality management
system shall be available and be maintained as
documented information. The scope shall state the
types of products and services covered, and provide
justification for any requirement of this International
Standard that the organization determines is not
applicable to the scope of its quality management
system.

29
Conformity to this International Standard may only be
claimed if the requirements determined as not being
applicable do not affect the organization’s ability or
responsibility to ensure the conformity of its products
and services and the enhancement of customer
satisfaction.

30
 Clause 4: Context of the
Organization
• 4.3. Determining the scope of(3)
the QMS
• 4.4. QMS and its Processes

31
4.4. Quality management system and its processes
4.4.1. The organization shall establish, implement,
maintain and continually improve a quality
management system, including the processes needed
and their interactions, in accordance with the
requirements of this International Standard.
The organization shall determine the processes
needed for the quality management system and their
application throughout the organization, and shall:

32
a) determine the inputs required and the outputs
expected from these processes;
b) determine the sequence and interaction of these
processes;
c) determine and apply the criteria and methods
(including monitoring, measurements and related
performance indicators) needed to ensure the
effective operation and control of these processes;
d) determine the resources needed for these
processes and ensure their availability;

33
e) assign the responsibilities and authorities for these
processes;
f) address the risks and opportunities as determined
in accordance with the requirements of 6.1;
g) evaluate these processes and implement any
changes needed to ensure that these processes
achieve their intended results;
h) improve the processes and the quality management
system.

34
4.4.2. To the extent necessary, the organization shall:
a) maintain documented information to support the
operation of its processes;
b) retain documented information to have confidence
that the processes are being carried out as
planned.

35
36
Key concepts : Process
With what? With who?
(resources) (responsibilities,
authorities)

Inputs?
(what, Outputs?
from PROCESS (what,
whom) to whom)

How done? What results?

(criteria, methods/controls (monitoring, measurements,
documentation) performance indicators)

37
 Key concepts Process Approach
• A Coherent System:

(Interactions)
• Activities
understood
and managed as
• Understanding (Outputs)
interrelated
requirements (Inputs)
processes
Process
Intended
results

Consistent,
predictable results
• Processes adding value
Meeting requirements
Processes providing effective performance
Improvements (through evaluation) of data/information Customer satisfaction
PDCA (process) methodology

38
Representation of the structure of this
International Standard in the PDCA cycle
Quality Management System (4)

Organization and
its context (4) Support and
Operation
( 7,8)
Customer
Plan Do satisfaction

Customer
Leadership Performance Results of
requirements Planning (6)
(5) evaluation (9) the QMS

Act Products and

Check
services
Improvement
Needs and (10)
expectations
of relevant
interested
parties (4)

39
 Business Process

SP-01 WI-XX-01
CP-01 PP-01

Order Processing
Planning

SP-02
CP-02 WI-XX-02

Purchasing RID-01
Logistics

SP-03 QA, MR

40
41
 Structure of quality management system and documentation
Sample 1
<Process > < Procedure> < W.I. >

Human resource
ISO 9001 Quality Management System

management process

Sales marketing process

Purchasing information control
instruction
Equipment control
Supplier evaluation criteria
Production procedure
Purchasing procedure Products inspection criteria
management process Production procedure Purchasing criteria
Inspection procedure Inquiry, negotiation and
comparison of price

Design and research

process

Financial management
process

42
 MATRIX OF DOCUMENTS - STANDARD

Clause ISO 9001

Departement/ Name of No
No Procedu ……..
Process document Doc- ……..
re

43
 5

Leadership
Clause 5 - ISO 9001:2015

44
 Leadership and
commitment for the
quality management
system
5.1. Leadership and
commitment

Customer focus

5. Leadership 5.2. Quality policy

5.3. Organizational
roles, responsibilities
and authorities

45
5. Leadership
5.1. Leadership and commitment
5.5.1. General
Top management shall demonstrate leadership and
commitment with respect to the quality management
system by:
a) taking accountability for the effectiveness of the
quality management system;
b) ensuring that the quality policy and quality
objectives are established for the quality management
system and are compatible with the context and
strategic direction of the organization;

46
5. LEADERSHIP

c) ensuring the integration of the quality

management system requirements into the
organization’s business processes;
d) promoting the use of the process approach
and risk-based thinking;
e) ensuring that the resources needed for the
quality management system are available;
f) communicating the importance of effective
quality management and of conforming to the
quality management system requirements;

47
5. LEADERSHIP

g) ensuring that the quality management

system achieves its intended results;
h) engaging, directing and supporting
persons to contribute to the
effectiveness of the quality management
system;
i) promoting improvement;
j) supporting other relevant
management roles to demonstrate their
leadership as it applies to their areas of
responsibility.

48
5. LEADERSHIP
5.1.2. Customer focus
Top management shall demonstrate leadership and
commitment with respect to customer focus by ensuring
that:
a) customer and applicable statutory and regulatory
requirements are determined, understood and
consistently met;
b) the risks and opportunities that can affect conformity of
products and services and the ability to enhance customer
satisfaction are determined and addressed;
c) the focus on enhancing customer satisfaction is
maintained.

49
5. LEADERSHIP
5.2. Policy
5.2.1. Establishing the quality policy
Top management shall establish, implement and
maintain a quality policy that:
a) is appropriate to the purpose and context of the
organization and supports its strategic direction;
b) provides a framework for setting quality objectives;
c) includes a commitment to satisfy applicable
requirements;
d) includes a commitment to continual improvement of
the quality management system.

50
5. LEADERSHIP

5.2.2. Communicating the quality policy

The quality policy shall:
a) be available and be maintained as documented
information;
b) be communicated, understood and applied within
the organization;
c) be available to relevant interested parties, as
appropriate.

51
5. LEADERSHIP
5.3. Organizational roles, responsibilities and
authorities
Top management shall ensure that the responsibilities
and authorities for relevant roles are assigned,
communicated and understood within the
organization.
Top management shall assign the responsibility and
authority for:
a) ensuring that the quality management system conforms
to the requirements of this International Standard;
b) ensuring that the processes are delivering their
intended outputs;

52
5. LEADERSHIP

c) reporting on the performance of the quality

management system and on opportunities for
improvement (see 10.1), in particular to top
management;
d) ensuring the promotion of customer focus
throughout the organization;
e) ensuring that the integrity of the quality
management system is maintained when changes to
the quality management system are planned and
implemented.

53
 6

Planning
Clause 6 - ISO 9001:2015

54
 Clause 6: Planning for the QMS
6.1. Actions to address risks and opportunities
6.2. Quality objectives and planning to achieve them
6.3. Planning of changes
4.1
Issues

6.1
Determine risks and opportunities

9.2

6.1
Plan actions to address risks and opportunities

55
6. PLANNING
6.1. Actions to address risks and opportunities
6.1.1. When planning for the quality management
system, the organization shall consider the issues
referred to in 4.1 and the requirements referred to in
4.2 and determine the risks and opportunities that
need to be addressed to:
a) give assurance that the quality management system
can achieve its intended result(s);
b) enhance desirable effects;
c) prevent, or reduce, undesired effects;
d) achieve improvement.

56
6. PLANNING
6.1.2. The organization shall plan:
a) actions to address these risks and opportunities;
b) how to:
1) integrate and implement the actions into its quality
management system processes (see 4.4);
2) evaluate the effectiveness of these actions.
Actions taken to address risks and opportunities shall
be proportionate to the potential impact on the
conformity of products and services.

57
 One can “slice and dice” these multiple
dimensions of risk

“Specific
Risk”
Equity Risk Trading Risk
Market Risk General
Interest Rate Risk Market
Gap Risk Risk
Currency Risk
Credit Risk
Commodity Risk
Counterparty
Operational Risk
Risk
Transaction Risk
Risks
Reputational Issuer Risk
Risk Portfolio
Concentration
Risk Issue Risk
Business and
strategic risks

58
Threat map

59
Business Risk Assessment Process

Identify Assessment Assessment Business

Risk of Risk of Controls Management
Strategy
Understand Assess Assess Planning
Implementation
and analyse business implemented Monitoring
the business risk risk control Improvement

Focus on Prioritising Improved Managed

strategic of critical internal Business
issues risk control

60
 Risk context, assessment and treatment
Relevant
Issues
(from Risk
Risk Analysis Risk Evaluation Risk Treatment Residual risk
context) Identification
red = -ve
green = +ve

Neighbourhoo
d disruption
in street
cabling

New fibre
technology
available

Workforce
retention

Economic – Impact significant Unable to Subscribe to Economic Unknown pending

Significant effect but likelihood qualify as indicators service for horizon scan. Re-
Share on profit unknown (high likelihood horizon scanning economic evaluate on report
holders: Stock objectives and uncertainty) unknown conditions and global trends receipt. Tolerate
market crash liquidity if share risk. Transfer
price collapses emergency funds to
holding company

61
 SAMPLE - LIST OF RISK ITEMS
Organizational Terms & Conditions
Design Engineering Risks Procurement Risks HSE Risks Project Management Risks
Risks Contract Risks
FEED Docs in ITB Docs are not detail RFQ & RFP documents are not HSE Project Plan Project purpose and need is not well- Inexperienced staff Refer To Legal Analysis on
and incomplete additional some clear such as : Scope of Supply, Implementation. High standard defined assigned Draft of Contract from
procentage for Bill of Quantity Data Sheet, Bill of Quantity, will impact to project cost and Legal Department or
calculation may required. Specification, Test Witness, schedule Refer to Analysis from
Chemical /Oil/Grease Supply, Contract Engineer
Spare Part For Commissioning & 2
Years Operations, engineering
document should be supply,
Fabrication Schedule, Packaging
Specification, General Condition,
etc are not clear.
Plot Plan, P&ID, One Line Diagram & Critical Items and Very tight Risk Register and Risk Project scope, schedule, objectives, Losing critical staff at
Hazardous Area Change Schedule that need special Management Execution are not cost, and deliverables are not clearly crucial time of the
attentions well done since Engineering defined or understood project
Design Stage.
Inaccurate assumptions on Increase in material cost due to Environmental analysis Unreasonably high expectations from Insufficient time to
technical issues in planning stage market forces (AMDAL) incomplete stakeholders plan
Surveys incomplete Political Situation is unstable, War, Environmental regulation or Vendor or contractor delays Unanticipated project
Riot, Embargo local regulation is not Clear or manager workload
Changed
Changes to Capacity, Materials or Economic is Unstable, Depression, Construction Waste Treatment Estimating and/or scheduling errors Internal “red tape”
Specification Inflasion, Currency Rate is Availability causes delay getting
unstable, Oil Price is unstable or approvals, decisions
increase.
SIL, HAZID & HAZOP Study have Disaster, Climate, High/Low Tide Availability of project data and Unplanned work that must be Functional units not
potensial to add more materials, and Other Nature Conditions. mapping at the beginning of accommodated available, overloaded
instrument & equipments. the environmental study is
insufficient
Basic Engineering Design Data & Massive Development or Massive New information after Lack of coordination/communication Lack of specialized
Detail Engineering Design Data are Construction in some country or Environmental Document is staff or Skilled MP
wrong. Province that requires a lot of completed may require re- resources are limited.
Cosntruction materials evaluation or a new document
(i.e. utility relocation beyond
document coverage)
P&ID and Plot Plan Review Meeting Loading & Unloading and New alternatives required to Underestimated support resources or Overlapping of one or
are not so carefully done so it does Transportation Plan which need avoid, mitigate or minimize overly optimistic delivery schedule more projects
not find a crucial problem special attentions impact
Don't Consider Operability, Import & Export Regulations are Design changes require Inaccurate contract time estimates
Maintainability & Constructability changed additional Environmental
analysis
Approval Procedure for Engineering Procurement Planning & Control Unanticipated Noise, Air Unresolved project conflicts not
Products is very long are wrong Quality and Waste impacts escalated in a timely manner
62
Project causes an unanticipated Unanticipated escalation in right of
barrier to wildlife way values or construction cost
63
64
65
 A Closer Look

The FMEA Form

Identify failure modes Determine and assess

Identify causes of the Prioritize
and their effects actions
failure modes
and controls

66
6. PLANNING
6.2. Quality objectives and planning to achieve them
6.2.1. The organization shall establish quality
objectives at relevant functions, levels and processes
needed for the quality management system.
The quality objectives shall:
a) be consistent with the quality policy;
b) be measurable;
c) take into account applicable requirements;

67
6. PLANNING

d) be relevant to conformity of products and services

and to enhancement of customer satisfaction;
e) be monitored;
f) be communicated;
g) be updated as appropriate.
The organization shall maintain documented
information on the quality objectives.

68
6. PLANNING

6.2.2. When planning how to achieve its quality

objectives, the organization shall determine:
• what will be done;
• what resources will be required;
• who will be responsible;
• when it will be completed;
• how the results will be evaluated.

69
Objective and Effort of the whole institution
Current Future
Situation progressing Situation

Risk Analysis
Risk A Vision
Objectives A

Risk B Mission
Objectives B

Institusional
Risk C
objectives
Objectives C

Performance
indicators

70
6. PLANNING

6.3. Planning of changes

When the organization determines the need for
changes to the quality management system, the
changes shall be carried out in a planned manner (see
4.4).
The organization shall consider:
a) the purpose of the changes and their potential
consequences;
b) the integrity of the quality management system;
c) he availability of resources;
d) the allocation or reallocation of responsibilities and
authorities.

71
6.3. ‘Planning of Changes’

• Planning/implementing QMS changes (6.3),

• Controlling operational changes, planned and
unintentional (8.1)
• Addressing unplanned changes affecting products
& services (8.5.6)
• See also 7.1.6 Organizational knowledge - for
addressing changing needs and trends, with
respect to knowledge

72
 7

Resources
Clause 7 - ISO 9001:2015

73
Clause 7: Support

• 7.1 – Resources
• Determine and provide the necessary resources including people,
infrastructure, operational processes, and knowledge

• 7.2 – Competence
• Identify and maintain competence

• 7.3 – Awareness
• Make objectives known, and ensure awareness of QMS

• 7.4 – Communication
• What, when, how, who, and to whom

• 7.5 – Documented information

• Reflects variety of sources and need to back up information

74
7. Support
7.1. Resources
7.1.1. General
The organization shall determine and provide the
resources needed for the establishment,
implementation, maintenance and continual
improvement of the quality management system.
The organization shall consider:
a) the capabilities of, and constraints on, existing
internal resources;
b) what needs to be obtained from external
providers.

75
7. SUPPORT
7.1.2. People
The organization shall determine and provide the
persons necessary for the effective implementation
of its quality management system and for the
operation and control of its processes.

7.1.3. Infrastructure
The organization shall determine, provide and
maintain the infrastructure necessary for the
operation of its processes and to achieve conformity
of products and services.

76
7. SUPPORT

7.1.4. Environment for the operation of processes

The organization shall determine, provide and
maintain the environment necessary for the operation
of its processes and to achieve conformity of products
and services.

77
7. SUPPORT
7.1.5. Monitoring and measuring
resources
7.1.5.1. General
The organization shall determine and
provide the resources needed to ensure
valid and reliable results when
monitoring or measuring is used to verify
the conformity of products and services to
requirements.
The organization shall ensure that the
resources provided:
a) are suitable for the specific type of
monitoring and measurement activities
being undertaken;

78
7. SUPPORT

b) are maintained to ensure their continuing fitness

for their purpose.
The organization shall retain appropriate documented
information as evidence of fitness for purpose of the
monitoring and measurement resources.

79
7. SUPPORT
7.1.5.2. Measurement traceability
When measurement traceability is a requirement, or
is considered by the organization to be an essential
part of providing confidence in the validity of
measurement results, measuring equipment shall be:
a) calibrated or verified, or both, at specified intervals,
or prior to use, against measurement standards
traceable to international or national measurement
standards; when no such standards exist, the basis
used for calibration or verification shall be retained as
documented information;

80
7. SUPPORT

b) identified in order to determine their status;

c) safeguarded from adjustments, damage or
deterioration that would invalidate the calibration
status and subsequent measurement results.
The organization shall determine if the validity of
previous measurement results has been adversely
affected when measuring equipment is found to be
unfit for its intended purpose, and shall take
appropriate action as necessary.
•

81
7. SUPPORT
7.1.6. Organizational knowledge
The organization shall determine the knowledge
necessary for the operation of its processes and to
achieve conformity of products and services.
This knowledge shall be maintained and be made
available to the extent necessary.
When addressing changing needs and trends, the
organization shall consider its current knowledge and
determine how to acquire or access any necessary
additional knowledge and required updates.

82
7.1.6. Organisational Knowledge

• Defined as ‘available collection of information (meaningful data –

facts about an object) being a justified belief and having a high
certainty to be true’.
• This can include information such as intellectual property and
lessons learned.
• The requirement here is to determine, maintain and make available
(extent necessary) the knowledge necessary for the operation of its
processes, AND to achieve conformity of products and services.
• Knowledge necessary to address changing needs and trends will
also need considering, and how to acquire or access any
additional knowledge necessary.
• Sources: (Internal) learning from failure/success, capturing
knowledge of experts, etc. (External) academia, standards,
conferences, customers, external providers etc.

83
7. SUPPORT
7.2. Competence
The organization shall:
a) determine the necessary competence of person(s) doing
work under its control that affects the performance and
effectiveness of the quality management system;
b) ensure that these persons are competent on the basis of
appropriate education, training, or experience;
c) where applicable, take actions to acquire the necessary
competence, and evaluate the effectiveness of the actions
taken;
d) retain appropriate documented information as evidence
of competence.

84
7. SUPPORT
7.3. Awareness
The organization shall ensure that persons doing work
under the organization’s control are aware of:
a) the quality policy;
b) relevant quality objectives;
c) their contribution to the effectiveness of the quality
management system, including the benefits of
improved performance;
d) the implications of not conforming with the quality
management system requirements.

85
 7. SUPPORT
7.4. Communication
The organization shall determine the internal and
external communications relevant to the quality
management system, including:
a) on what it will communicate;
b) when to communicate;
c) with whom to communicate;
d) how to communicate;
e) who communicates.

86
7. SUPPORT

7.5. Documented information

7.5.1. General
The organization’s quality management system shall
include:
a) documented information required by this
International Standard;
b) documented information determined by the
organization as being necessary for the effectiveness
of the quality management system.

87
7. SUPPORT
7.5.2. Creating and updating
When creating and updating documented
information, the organization shall ensure
appropriate:
a) identification and description (e.g. a title, date,
author, or reference number);
b) format (e.g. language, software version, graphics)
and media (e.g. paper, electronic);
c) review and approval for suitability and adequacy.

88
7. SUPPORT

7.5.3. Control of documented information

7.5.3.1. Documented information required by the
quality management system and by this International
Standard shall be controlled to ensure:
a) it is available and suitable for use, where and when
it is needed;
b) it is adequately protected (e.g. from loss of
confidentiality, improper use, or loss of integrity).

89
7. SUPPORT

7.5.3.2. For the control of documented information,

the organization shall address the following activities,
as applicable:
a) distribution, access, retrieval and use;
b) storage and preservation, including preservation of
legibility;
c) control of changes (e.g. version control);
d) retention and disposition.

90
7. SUPPORT

Documented information of external origin

determined by the organization to be necessary for
the planning and operation of the quality
management system shall be identified as
appropriate, and be controlled.
Documented information retained as evidence of
conformity shall be protected from unintended
alterations.

91
 8

Operational
Clause 8 - ISO 9001:2015

92
 Clause 8: Operation
Operational planning and
control

Requirements for products and

services

Design and development of product‘s’ and

services
Control of externally provided products and
services

Production and service

provision, including
release

Control of nonconforming
process…
93
8. Operation
8.1. Operational planning and control
The organization shall plan, implement and control
the processes (see 4.4) needed to meet the
requirements for the provision of products and
services, and to implement the actions determined in
Clause 6, by:
a) determining the requirements for the products and
services;
b) establishing criteria for:
1) the processes;
2) the acceptance of products and services;

94
8. OPERATION
c) determining the resources needed to achieve
conformity to the product and service requirements;
d) implementing control of the processes in
accordance with the criteria;
e) determining, maintaining and retaining
documented information to the extent necessary:
1) to have confidence that the processes have been
carried out as planned;
2) to demonstrate the conformity of products and services
to their requirements. The output of this planning shall
be suitable for the organization’s operations.

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8. OPERATION

The organization shall control planned changes and

review the consequences of unintended changes,
taking action to mitigate any adverse effects, as
necessary.
The organization shall ensure that outsourced
processes are controlled (see 8.4).

96
8. OPERATION
8.2. Requirements for products and services
8.2.1. Customer communication
Communication with customers shall include:
a) providing information relating to products and services;
b) handling enquiries, contracts or orders, including
changes;
c) obtaining customer feedback relating to products and
services, including customer complaints;
d) handling or controlling customer property;
e) establishing specific requirements for contingency
actions, when relevant.

97
8. OPERATION
8.2.2. Determining the requirements for products
and services
When determining the requirements for the products
and services to be offered to customers, the
organization shall ensure that:
a) the requirements for the products and services are
defined, including:
1) any applicable statutory and regulatory requirements;
2) those considered necessary by the organization;
b) the organization can meet the claims for the
products and services it offers.

98
8. OPERATION
8.2.3. Review of the requirements for products and
services
8.2.3.1. The organization shall ensure that it has the
ability to meet the requirements for products and
services to be offered to customers. The organization
shall conduct a review before committing to supply
products and services to a customer, to include:
a) requirements specified by the customer, including
the requirements for delivery and post- delivery
activities;

99
8. OPERATION

b) requirements not stated by the customer, but

necessary for the specified or intended use, when
known;
c) requirements specified by the organization;
d) statutory and regulatory requirements applicable to
the products and services;
e) contract or order requirements differing from those
previously expressed.

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8. OPERATION

The organization shall ensure that contract or order

requirements differing from those previously defined
are resolved.
The customer’s requirements shall be confirmed by
the organization before acceptance, when the
customer does not provide a documented statement
of their requirements.

101
8. OPERATION

8.2.3.2. The organization shall retain documented

information, as applicable:
a) on the results of the review;
b) on any new requirements for the products and
services.

102
8. OPERATION

8.2.4. Changes to requirements for products and

services
The organization shall ensure that relevant
documented information is amended, and that
relevant persons are made aware of the changed
requirements, when the requirements for products
and services are changed.

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8. OPERATION

8.3. Design and development of products and

services
8.3.1. General
The organization shall establish, implement and
maintain a design and development process that is
appropriate to ensure the subsequent provision of
products and services.

104
8. OPERATION
8.3.2. Design and development planning
In determining the stages and controls for design and
development, the organization shall consider:
a) the nature, duration and complexity of the design
and development activities;
b) the required process stages, including applicable
design and development reviews;
c) the required design and development verification
and validation activities;
d) the responsibilities and authorities involved in the
design and development process;

105
8. OPERATION

e) the internal and external resource needs for the

design and development of products and services;
f) the need to control interfaces between persons
involved in the design and development process;
g) the need for involvement of customers and users in
the design and development process;
h) the requirements for subsequent provision of
products and services;

106
8. OPERATION

i) the level of control expected for the design and

development process by customers and other relevant
interested parties;
j) the documented information needed to
demonstrate that design and development
requirements have been met.

107
8. OPERATION
8.3.3. Design and development inputs
The organization shall determine the requirements
essential for the specific types of products and services to
be designed and developed. The organization shall
consider:
a) functional and performance requirements;
b) information derived from previous similar design and
development activities;
c) statutory and regulatory requirements;
d) standards or codes of practice that the organization has
committed to implement;
e) potential consequences of failure due to the nature of the
products and services.

108
8. OPERATION

Inputs shall be adequate for design and development

purposes, complete and unambiguous.
Conflicting design and development inputs shall be
resolved.
The organization shall retain documented information
on design and development inputs.

109
8. OPERATION

8.3.4. Design and development controls

The organization shall apply controls to the design and
development process to ensure that:
a) the results to be achieved are defined;
b) reviews are conducted to evaluate the ability of the
results of design and development to meet
requirements;
c) verification activities are conducted to ensure that
the design and development outputs meet the input
requirements;

110
8. OPERATION

d) validation activities are conducted to ensure that

the resulting products and services meet the
requirements for the specified application or intended
use;
e) any necessary actions are taken on problems
determined during the reviews, or verification and
validation activities;
f) documented information of these activities is
retained.

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8. OPERATION
8.3.5. Design and development outputs
The organization shall ensure that design and
development outputs:
a) meet the input requirements;
b) are adequate for the subsequent processes for the provision
of products and services;
c) include or reference monitoring and measuring
requirements, as appropriate, and acceptance criteria;
d) specify the characteristics of the products and services that
are essential for their intended purpose and their safe and
proper provision.
The organization shall retain documented information
on design and development outputs.

112
8. OPERATION
8.3.6. Design and development changes
The organization shall identify, review and control
changes made during, or subsequent to, the design
and development of products and services, to the
extent necessary to ensure that there is no adverse
impact on conformity to requirements.
The organization shall retain documented information
on:
a) design and development changes;
b) the results of reviews;
c) the authorization of the changes;
d) the actions taken to prevent adverse impacts.

113
8. OPERATION
8.4. Control of externally provided processes, products and
services
• 8.4.1. General
The organization shall ensure that externally provided
processes, products and services conform to
requirements.
The organization shall determine the controls to be
applied to externally provided processes, products
and services when:
a) products and services from external providers are
intended for incorporation into the organization’s own
products and services;

114
8. OPERATION

b) products and services are provided directly to the

customer(s) by external providers on behalf of the
organization;
c) a process, or part of a process, is provided by an
external provider as a result of a decision by the
organization.

115
8. OPERATION

The organization shall determine and apply criteria for

the evaluation, selection, monitoring of performance,
and re-evaluation of external providers, based on their
ability to provide processes or products and services
in accordance with requirements. The organization
shall retain documented information of these
activities and any necessary actions arising from the
evaluations.

116
8. OPERATION
8.4.2. Type and extent of control
The organization shall ensure that externally provided
processes, products and services do not adversely
affect the organization’s ability to consistently deliver
conforming products and services to its customers.
The organization shall:
a) ensure that externally provided processes remain within
the control of its quality management system;
b) define both the controls that it intends to apply to an
external provider and those it intends to apply to the
resulting output;

117
8. OPERATION

c) take into consideration:

1) the potential impact of the externally provided
processes, products and services on the organization’s
ability to consistently meet customer and applicable
statutory and regulatory requirements;
2) the effectiveness of the controls applied by the
external provider;
d) determine the verification, or other activities, necessary
to ensure that the externally provided processes, products
and services meet requirements.

118
8. OPERATION
8.4.3. Information for external providers
The organization shall ensure the adequacy of
requirements prior to their communication to the
external provider.
The organization shall communicate to external
providers its requirements for:
a) the processes, products and services to be
provided;
b) the approval of:
1) products and services;
2) methods, processes and equipment;
3) the release of products and services;

119
8. OPERATION
c) competence, including any required qualification of
persons;
d) the external providers’ interactions with the
organization;
e) control and monitoring of the external providers’
performance to be applied by the organization;
f) verification or validation activities that the
organization, or its customer, intends to perform at
the external providers’ premises.

120
8. OPERATION
8.5. Production and service provision
8.5.1. Control of production and service provision
The organization shall implement production and
service provision under controlled conditions.
Controlled conditions shall include, as applicable:
a) the availability of documented information that
defines:
1) the characteristics of the products to be produced, the
services to be provided, or the activities to be performed;
2) the results to be achieved;

121
8. OPERATION
b) the availability and use of suitable monitoring and
measuring resources;
c) the implementation of monitoring and
measurement activities at appropriate stages to verify
that criteria for control of processes or outputs, and
acceptance criteria for products and services, have
been met;
d) the use of suitable infrastructure and environment
for the operation of processes;
e) the appointment of competent persons, including
any required qualification;

122
8. OPERATION

f) the validation, and periodic revalidation, of the

ability to achieve planned results of the processes for
production and service provision, where the resulting
output cannot be verified by subsequent monitoring
or measurement;
g) the implementation of actions to prevent human
error;
h) the implementation of release, delivery and post-
delivery activities.

123
8. OPERATION
8.5.2. Identification and traceability
The organization shall use suitable means to identify
outputs when it is necessary to ensure the conformity
of products and services.
The organization shall identify the status of outputs
with respect to monitoring and measurement
requirements throughout production and service
provision.
The organization shall control the unique
identification of the outputs when traceability is a
requirement, and shall retain the documented
information necessary to enable traceability.

124
8. OPERATION
8.5.3. Property belonging to customers or external
providers
The organization shall exercise care with property belonging to
customers or external providers while it is under the
organization’s control or being used by the organization.
The organization shall identify, verify, protect and safeguard
customers’ or external providers’ property provided for use or
incorporation into the products and services.
When the property of a customer or external provider is lost,
damaged or otherwise found to be unsuitable for use, the
organization shall report this to the customer or external
provider and retain documented information on what has
occurred.

125
8. OPERATION

8.5.4. Preservation
The organization shall preserve the outputs during
production and service provision, to the extent
necessary to ensure conformity to requirements.

126
8. OPERATION

8.5.5. Post-delivery activities

The organization shall meet requirements for post-
delivery activities associated with the products and
services.

127
8. OPERATION

In determining the extent of post-delivery activities

that are required, the organization shall consider:
a) statutory and regulatory requirements;
b) the potential undesired consequences associated
with its products and services;
c) the nature, use and intended lifetime of its products
and services;
d) customer requirements;
e) customer feedback.

128
8. OPERATION
8.5.6. Control of changes
The organization shall review and control changes for
production or service provision, to the extent
necessary to ensure continuing conformity with
requirements.
The organization shall retain documented information
describing the results of the review of changes, the
person(s) authorizing the change, and any necessary
actions arising from the review.

129
8. OPERATION
8.6. Release of products and services
The organization shall implement planned
arrangements, at appropriate stages, to verify that the
product and service requirements have been met.
The release of products and services to the customer
shall not proceed until the planned arrangements
have been satisfactorily completed, unless otherwise
approved by a relevant authority and, as applicable,
by the customer.

130
8. OPERATION

The organization shall retain documented information

on the release of products and services. The
documented information shall include:
a) evidence of conformity with the acceptance
criteria;
b) traceability to the person(s) authorizing the
release.

131
8. OPERATION
8.7. Control of nonconforming outputs
8.7.1. The organization shall ensure that outputs that
do not conform to their requirements are identified
and controlled to prevent their unintended use or
delivery.
The organization shall take appropriate action based
on the nature of the nonconformity and its effect on
the conformity of products and services. This shall
also apply to nonconforming products and services
detected after delivery of products, during or after the
provision of services.

132
8. OPERATION
The organization shall deal with nonconforming
outputs in one or more of the following ways:
a) correction;
b) segregation, containment, return or suspension of
provision of products and services;
c) informing the customer;
d) obtaining authorization for acceptance under
concession.
Conformity to the requirements shall be verified when
nonconforming outputs are corrected.

133
8. OPERATION

8.7.2. The organization shall retain documented

information that:
a) describes the nonconformity;
b) describes the actions taken;
c) describes any concessions obtained;
d) identifies the authority deciding the action in
respect of the nonconformity.

134
 9

Performance Evaluation
Clause 9 - ISO 9001:2015

135
Clause 9 – Performance evaluation
• 9.1 – Monitoring, measurement, analysis and evaluation
• What needs to be monitored and measured, how and when
• 9.2 – Internal audit
• To establish whether the QMS conforms to requirements and is
effectively implemented and maintained
• 9.3 – Management review
• Top management must regularly review the QMS

136
 Clause 9 – Performance
9.1.evaluation
Monitoring, measurement,
• What needs to be monitored and measured,
analysis and evaluationhow and when

9.1.3

(Analysis and
evaluation)

9.1.2

(Customer
9.1.1 satisfaction)

(General)

137
9. PERFORMANCE EVALUATION
9. Performance evaluation
9.1. Monitoring, measurement, analysis and
evaluation
9.1.1. General
The organization shall determine:
a) what needs to be monitored and measured;
b) the methods for monitoring, measurement, analysis
and evaluation needed to ensure valid results;
c) when the monitoring and measuring shall be
performed;

138
9. PERFORMANCE EVALUATION

d) when the results from monitoring and

measurement shall be analysed and evaluated.
The organization shall evaluate the performance and
the effectiveness of the quality management system.
The organization shall retain appropriate documented
information as evidence of the results.

139
9. PERFORMANCE EVALUATION

9.1.2. Customer satisfaction

The organization shall monitor customers’ perceptions
of the degree to which their needs and expectations
have been fulfilled. The organization shall determine
the methods for obtaining, monitoring and reviewing
this information.

140
9.1.2. Customer Satisfaction

UNANTICIPATED
DESIRED
EXPECTED
BASIC

Purchasing factors
Loyalty factors

141
9. PERFORMANCE EVALUATION
9.1.3. Analysis and evaluation
The organization shall analyse and evaluate
appropriate data and information arising from
monitoring and measurement.
The results of analysis shall be used to evaluate:
a) conformity of products and services;
b) the degree of customer satisfaction;
c) the performance and effectiveness of the quality
management system;
d) if planning has been implemented effectively;

142
9. PERFORMANCE EVALUATION

e) the effectiveness of actions taken to address risks

and opportunities;
f) the performance of external providers;
g) the need for improvements to the quality
management system.

143
 Clause 9 – Performance
evaluation
9.2. Internal Audit
To establish whether the QMS conforms to
requirements and is effectively implemented and
maintained

Ensure
At planned system Ensure Effectively
intervals conforms to system implement Follow-up
(status and planned conforms to ed and actions
importance) arrangement ISO 9001 maintained
s

Audit criteria, scope, frequency, methods defined in documented

information

144
9. PERFORMANCE EVALUATION

9.2. Internal audit

9.2.1. The organization shall conduct internal audits at
planned intervals to provide information on whether
the quality management system:
a) conforms to:
1) the organization’s own requirements for its
quality management system;
2) the requirements of this International Standard;
b) is effectively implemented and maintained.

145
9. PERFORMANCE EVALUATION

9.2.2. The organization shall:

a) plan, establish, implement and maintain an audit
programme(s) including the frequency, methods,
responsibilities, planning requirements and reporting,
which shall take into consideration the importance of
the processes concerned, changes affecting the
organization, and the results of previous audits;
b) define the audit criteria and scope for each audit;

146
9. PERFORMANCE EVALUATION
c) select auditors and conduct audits to ensure
objectivity and the impartiality of the audit process;
d) ensure that the results of the audits are reported to
relevant management;
e) take appropriate correction and corrective actions
without undue delay;
f) retain documented information as evidence of the
implementation of the audit programme and the audit
results.

147
9. PERFORMANCE EVALUATION

9.3. Management review

9.3.1. General
Top management shall review the organization’s
quality management system, at planned intervals, to
ensure its continuing suitability, adequacy,
effectiveness and alignment with the strategic
direction of the organization.

148
9. PERFORMANCE EVALUATION
9.3.2. Management review inputs
The management review shall be planned and carried
out taking into consideration:
a) the status of actions from previous management
reviews;
b) changes in external and internal issues that are
relevant to the quality management system;
c) information on the performance and effectiveness
of the quality management system, including trends
in:
1) customer satisfaction and feedback from relevant
interested parties;

149
9. PERFORMANCE EVALUATION
2) the extent to which quality objectives have been met;
3) process performance and conformity of products and
services;
4) nonconformities and corrective actions;
5) monitoring and measurement results;
6) audit results;
7) the performance of external providers;
d) the adequacy of resources;
e) the effectiveness of actions taken to address risks
and opportunities (see 6.1);
f) opportunities for improvement.

150
9. PERFORMANCE EVALUATION

9.3.3. Management review outputs

The outputs of the management review shall include
decisions and actions related to:
a) opportunities for improvement;
b) any need for changes to the quality management
system;
c) resource needs.
The organization shall retain documented information
as evidence of the results of management reviews.

151
 9.3. Management Review
CONSIDER: WHAT NEEDS
TO CHANGE?
Previous actions/
status
! !
External/ Opportunities (C.I)
internal issues

N/C’s,
corrective actions

Monitoring/
Measurement
REVIEW
Changes to QMS
Audit results

Customer satisfaction

External providers

Adequacy of
Resource needs
resources

Process performance

Risks and
opportunities

Continual Doc. Information

improvement (C.I)

152
10

Improvement
Clause 10- ISO 9001:2015

153
 Clause 10: Improvement
Improvement

Nonconformity and corrective

action

Continual improvement

154
10. IMPROVEMENT
10. Improvement
10.1. General
The organization shall determine and select
opportunities for improvement and implement any
necessary actions to meet customer requirements and
enhance customer satisfaction.
These shall include:
a) improving products and services to meet requirements as
well as to address future needs and expectations;
b) correcting, preventing or reducing undesired effects;
c) improving the performance and effectiveness of the quality
management system.

155
 What to How to
evaluate ? evaluate ?
• Policy
• Data collected Analyze
• Critical Success
Factor • Responsibility

• Measurement • Frequency

• Program • Method

Action

• Corrective
• Correction
• Improvement
10. IMPROVEMENT

10.2. Nonconformity and corrective action

When a nonconformity occurs, including any arising from
complaints, the organization shall:
a) react to the nonconformity and, as applicable:
1) take action to control and correct it;
2) deal with the consequences;
b) evaluate the need for action to eliminate the cause(s)
of the nonconformity, in order that it does not recur or
occur elsewhere, by:
1) reviewing and analysing the nonconformity;
2) determining the causes of the nonconformity;
3) determining if similar nonconformities exist, or could
potentially occur;

157
10. IMPROVEMENT
c) implement any action needed;
d) review the effectiveness of any corrective action
taken;
e) update risks and opportunities determined during
planning, if necessary;
f) make changes to the quality management system, if
necessary.
Corrective actions shall be appropriate to the effects
of the nonconformities encountered.

158
10. IMPROVEMENT

10.2.2. The organization shall retain documented

information as evidence of:
a) the nature of the nonconformities and any
subsequent actions taken;
b) the results of any corrective action.

159
10. IMPROVEMENT

10.3. Continual improvement

The organization shall continually improve the
suitability, adequacy and effectiveness of the quality
management system.
The organization shall consider the results of analysis
and evaluation, and the outputs from management
review, to determine if there are needs or
opportunities that shall be addressed as part of
continual improvement.

160
Continual improvement

QUALITY PROBLEM CORRECTIVE ACTION

• Operational Cost • Coordination between function

• Customer satisfaction Result • Caused identification

• Non conformity • Analysis & corrective action plan

• Performance • Follow up

• Health & Safety • Implementation monitoring,

efficiency and evaluation on its
effectiveness

PREVENTIVE ACTIONS
POTENTIAL • Caused identification
PROBLEMS
• Analysis & preventive action plan
• Implementation
• Implementation monitoring,
efficiency and evaluation on its CONTINUAL
effectiveness (Management Review) IMPROVEMENT
Review and Final Questions

162